BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIA-900

    MDR report key: 7344490 · Received March 16, 2018

    Report

    Report Number
    8031673-2018-02916
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    August 5, 2016
    Report Date
    March 16, 2018
    Manufacturer
    TOSOH CORPORATION
    Product Code
    KHO
    PMA / PMN Number
    K971103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. H.3. DEVICE EVALUATION BY MANUFACTURER: THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON 5 AUGUST 2016. THE FSE CHECKED THE LENS ON THE DETECTOR AND FOUND A LOT OF SPLASH ON THE LENS, THE ENGINEER CLEANED THE LENS AND RAN PRECISION. THE PRECISION RESULTS WERE REPORTED BY THE FSE TO BE GOOD. THE CUSTOMER EXPRESSED CONCERN REGARDING THE DIFFERENCES BETWEEN THE DILUTIONS ON PATIENTS WITH HIGH RESULTS, THE DILUTION FACTORS ARE X10, X100, X1000, THE FSE DOCUMENTED THE RESULTS BETWEEN THEM ARE NOT SIMILAR. THE ENGINEER FOUND A SMALL AIR LEAK IN BF2 THAT HE REPORTED MIGHT BE CAUSING ISSUE AND REALIGNED THE TIP TO THE D LANE, WHERE DILUTIONS ARE MADE. THE FSE ALSO CHANGED OUT THE WASH SYRINGE AND SAMPLE SYRINGE, THEN FLUSHED OUT THE SAMPLE NOZZLE WITH 20% BLEACH, THEN DI WATER AND CLEANED WITH AIR. THE ENGINEER MADE ADJUSTMENT TO THE BOTTOM OF THE SMALL BOTTLE. THE CUSTOMER THAN USED REPLACEMENT REAGENTS AND RAN PATIENT SAMPLES WITH 3 REPLICATES WITH VERY GOOD RESULTS. THE ENGINEER ALSO CHANGED THE TEST FILE SETTINGS. THE AIA-900 WAS WORKING AS INTENDED. NO FURTHER ACTION REQUIRED BY FSE. THE PROBABLE CAUSE OF THE EVENT WAS NOZZLE CONTAMINATION AND CLOGGED

    Description of Event or Problem · 0

    ON (B)(6) 2016 A CUSTOMER REPORTED DILUTION ACCURACY ON BHCG WITH THEIR AIA-900 ANALYZER. THE CUSTOMER REPORTEDLY RECENTLY PERFORMED LINEARIITY AND STATES IT PASSED BUT THE CUSTOMER REPORTED NO DILUTIONS WERE DONE. THE CUSTOMER INDICATES THE ISSUE IS WITH PATIENT SAMPLES RUN AT 100X DILUTION AND REPORTED GETTING VARIABLE ANSWERS OF 16000, 11000, 26000. THE CUSTOMER WAS UNABLE TO RUN SAMPLES AND REQUESTED SERVICE TO ADDRESS THE REPORTED EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAY REPORTING BHCG PATIENT RESULTS. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE EVENT CONSEQUENCE DUE TO THE DELAY OR ACCURACY OF REPORTING PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188174 AIA-900 AIA-900, PRODUCT CODE: KHO KHO TOSOH CORPORATION AIA-900

    Patients

    Seq Age Sex Outcome Treatment
    1